Gazette.govt.nzPursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
| Product: | Advil (General sale) |
| Active Ingredient: | Ibuprofen 200mg |
| Dosage Form: | Liquid filled capsule |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
| Manufacturers: | Catalent Australia Pty Limited, Melbourne, Australia Catalent Pharma Solutions LLC, Florida, United States of America |
| Product: | Advil (Pharmacy only) |
| Active Ingredient: | Ibuprofen 200mg |
| Dosage Form: | Liquid filled capsule |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
| Manufacturers: | Catalent Australia Pty Limited, Melbourne, Australia Catalent Pharma Solutions LLC, Florida, United States of America |
| Product: | Apo-Gabapentin |
| Active Ingredient: | Gabapentin 100mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Apotex NZ Limited |
| Manufacturer: | Apotex Inc, Toronto, Canada |
| Product: | Apo-Gabapentin |
| Active Ingredient: | Gabapentin 300mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Apotex NZ Limited |
| Manufacturer: | Apotex Inc, Toronto, Canada |
| Product: | Apo-Gabapentin |
| Active Ingredient: | Gabapentin 400mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Apotex NZ Limited |
| Manufacturer: | Apotex Inc, Toronto, Canada |
| Product: | Apo-Gabapentin |
| Active Ingredient: | Gabapentin 600mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Apotex NZ Limited |
| Manufacturer: | Apotex Inc, Toronto, Canada |
| Product: | Apo-Gabapentin |
| Active Ingredient: | Gabapentin 800mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Apotex NZ Limited |
| Manufacturer: | Apotex Inc, Toronto, Canada |
| Product: | De-Gas |
| Active Ingredient: | Simeticone 100mg |
| Dosage Form: | Liquid filled capsule |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
| Manufacturers: | Catalent Australia Pty Limited, Melbourne, Australia Catalent Ontario Limited, Windsor, Canada |
| Product: | Diarrhoea Relief |
| Active Ingredient: | Loperamide hydrochloride 2mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | PSM Healthcare Limited trading as API Consumer Brands |
| Manufacturers: | Adcock Ingram Limited - A Medreich Group Company, Bangalore, India Medreich Limited, Bangalore, India |
| Product: | Fluconazole-Baxter |
| Active Ingredient: | Fluconazole 2mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Baxter Healthcare Limited |
| Manufacturer: | Baxter Pharmaceuticals India Private Limited, Ahmedabad, India |
| Product: | Medrol |
| Active Ingredient: | Methylprednisolone 4mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Italia SrL, Ascoli Piceno, Italy |
| Product: | Medrol |
| Active Ingredient: | Methylprednisolone 100mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pfizer Manufacturing Belgium NV, Puurs, Belgium Pfizer Italia SrL, Ascoli Piceno, Italy |
| Product: | Merieux Inactivated Rabies Vaccine (MIRV) |
| Active Ingredient: | Rabies vaccine, Wistar PM/WI 38-1503-3M 2.5IU |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturers: | Sanofi Pasteur SA, Marcy L'Etoile, France Sanofi Pasteur SA, Val-De-Reuil, France |
| Product: | Ondansetron Kabi |
| Active Ingredient: | Ondansetron hydrochloride dihydrate 2.5mg/mL equivalent to ondansetron 2mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturer: | Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal |
| Product: | Solu-Medrol |
| Active Ingredient: | Methylprednisolone sodium succinate 1g |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pharmacia & Upjohn Company LLC, Michigan, United States of America Pfizer Manufacturing Belgium NV, Puurs, Belgium |
| Product: | Solu-Medrol Act-O-Vial |
| Active Ingredient: | Methylprednisolone sodium succinate 40mg/mL |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pharmacia & Upjohn Company LLC, Michigan, United States of America Pfizer Manufacturing Belgium NV, Puurs, Belgium |
| Product: | Solu-Medrol Act-O-Vial |
| Active Ingredient: | Methylprednisolone sodium succinate 62.5mg/mL |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pharmacia & Upjohn Company LLC, Michigan, United States of America Pfizer Manufacturing Belgium NV, Puurs, Belgium |
| Product: | Solu-Medrol Act-O-Vial |
| Active Ingredient: | Methylprednisolone sodium succinate 728.67mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pharmacia & Upjohn Company LLC, Michigan, United States of America Pfizer Manufacturing Belgium NV, Puurs, Belgium |
Dated this 14th day of February 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).